Senseonics Holdings, Inc.

Previous wording

In an effort to accelerate Ascensia’s commercialization efforts, we have taken steps to address challenges to Eversense adoption by establishing Eon Care, which maintains a network of nurses to perform insertions. We have also sought to complement Ascensia’s commercialization efforts by establishing a consignment program, whereby we sell the Eversense system and related components and supplies through a network of healthcare professionals, and supporting certain commercial programs such as direct to consumer (DTC) spending, certain key account activities, and market access support. Although the rate of Eversense adoption has increased following these initiatives, as well as the regulatory approval of Eversense 365, we continue to work closely with Ascensia to accelerate commercialization and further adoption of our product.

Current wording

In an effort to accelerate Ascensia’s commercialization efforts, we have taken steps to address challenges to Eversense adoption by establishing Eon Care, which maintains a network of nurses to perform insertions, fully transitioning a network of inserters to Eon Care from the Nurse Practitioner Group in the second quarter. We have sought to complement Ascensia’s commercialization efforts by establishing a consignment program, whereby we sell the Eversense system and related components and supplies through a network of healthcare professionals, and have seen an increase in the percentage of our U.S. sales that take place through the consignment program. We have also increased our support of certain commercial programs such as direct to consumer (DTC) spending, certain key account activities, and market access support. In recent quarters, we have invested greater amounts in commercial activities, and expect to continue enhanced investment, in DTC spending. Although the rate of Eversense adoption has increased following these initiatives, as well as the regulatory approval of Eversense 365, we continue to work closely with Ascensia to accelerate commercialization and further adoption of our product.

Previous wording

The Commercialization Agreement is terminable by either party if the other party materially breaches its obligations under the agreement; provided, however, that if Ascensia is unable to achieve the specified minimum spending or revenue targets outlined in the agreement, we will only have the right to convert Ascensia’s exclusive rights to nonexclusive rights. We regularly engage in discussions with Ascensia regarding the market opportunity for Eversense, the degree of spending on commercialization, and the potential impact of greater commercial support on product uptake. We also assess ways in which we can modify our plans and expand or introduce new commercial activities to accelerate commercialization and product adoption. As of the date of this report, we are assessing spending against targets for Ascensia’s fiscal year ended March 31, 2025, collaborating to determine what adjustments may be required in commercial support to better pursue the potential of Eversense, and considering any constraints to such support. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.

Current wording

The Commercialization Agreement is terminable by either party if the other party materially breaches its obligations under the agreement; provided, however, that if Ascensia is unable to achieve the specified minimum spending or revenue targets outlined in the agreement, we will only have the right to convert Ascensia’s exclusive rights to nonexclusive rights. We regularly engage in discussions with Ascensia regarding the market opportunity for Eversense, the degree of spending on commercialization, and the potential impact of greater commercial support on product uptake. We also assess ways in which we can modify our plans or arrangements, and expand or introduce new commercial activities to accelerate commercialization and product adoption. As of the date of this report, we continue to assess with Ascensia its spending against target requirements for Ascensia’s fiscal year ended March 31, 2025, the implications of any failure to meet such targets, and the commercial needs of the business. We continue to discuss with Ascensia what adjustments may be required in commercial support or our arrangements to better pursue the potential of Eversense, and consider any constraints to such support or arrangements. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.

Previous wording

We cannot guarantee this agreement with Ascensia will be successful, that it will continue, or that we will be able to achieve or maintain any particular volume of sales under the agreement or increase the volume of sales at a satisfactory pace or at all from this relationship in the future.

Current wording

The agreement is terminable by Ascensia under a number of circumstances, including if we undergo a change of control. The agreement is also terminable by either party if the other party undergoes bankruptcy, dissolution or winding up. We cannot guarantee this agreement with Ascensia will be successful, that it will continue, or that we will be able to achieve or maintain any particular volume of sales under the agreement or increase the volume of sales at a satisfactory pace or at all from this relationship in the future.

Previous wording

Our revenue is dependent, in part, upon the size of the markets in the territories for which we have regulatory approval or certification, the accepted price for the product, the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory. If the number of people with diabetes we target is not as

Current wording

Our revenue is dependent, in part, upon the size of the markets in the territories for which we have regulatory approval or certification, the accepted price for the product, the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory. If the number of people with diabetes we target is not as significant as we estimate or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products.

Previous wording

Our revenue is dependent on the success of Ascensia in commercializing our product and its future versions. Our product is a new product for Ascensia globally and they must continue to establish certain functions of their U.S. commercial organization to successfully market and sell our CGM system. Ascensia’s continued organizational development of its sales and marketing capabilities will be critical to successful commercialization of our Eversense systems. If Ascensia is unable to maintain effective sales, marketing and other functions that are required to support the product, or achieve the increased levels of commercial support needed to support product expansion, it will have a materially negative impact on our net revenues from Eversense. As of the date of this report, we are assessing spending against targets for Ascensia’s fiscal year ended March 31, 2025, collaborating to determine what adjustments may be required in commercial support to better pursue the potential of Eversense, and considering any constraints to such support. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.

Current wording

Our revenue is dependent on the success of Ascensia in commercializing our product and its future versions. Our product is a new product for Ascensia globally and they must continue to establish certain functions of their U.S. commercial organization to successfully market and sell our CGM system. Ascensia’s continued organizational development of its sales and marketing capabilities will be critical to successful commercialization of our Eversense systems. If Ascensia is unable to maintain effective sales, marketing and other functions that are required to support the product, or achieve the increased levels of commercial support needed to support product expansion, it will have a materially negative impact on our net revenues from Eversense. As of the date of this report, we continue to assess with Ascensia its spending against targets for Ascensia’s fiscal year ended March 31, 2025, the implications of any failure to meet such targets, and the commercial needs of the business. We continue to discuss with Ascensia what adjustments may be required in commercial support or our arrangements to better pursue the potential of Eversense, and consider any constraints to such support or arrangements. If we and/or Ascensia were to elect to modify our Commercialization Agreement or other commercial arrangements, such changes could subject us to additional risks or uncertainties associated with product commercialization.

Previous wording

Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the Notified Bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose "stop-sale" and "stop-import" orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product's design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense. The FDA, competent authorities of EEA countries and comparable foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company. Adverse regulatory action may restrict us from effectively marketing and selling our products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on our business, financial condition, and operating results.

Current wording

Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the Notified Bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose “stop-sale” and “stop-import” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product's design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense. The FDA, competent authorities of EEA countries and comparable

Previous wording

In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM. The development program seeks to integrate Eversense 365 and Sequel’s twiist™ automated insulin delivery system to enable improved outcomes for people living with diabetes. We currently expect the integration of the companies’ products to be available to consumers in the third quarter of 2025. The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:

Current wording

In April 2025, we entered into a collaboration agreement with Sequel Med Tech (the “Sequel Collaboration”), for the purpose of integrating the companies’ technologies to jointly create the first ever automated insulin delivery system with a once-yearly CGM. The development program seeks to integrate Eversense 365 and Sequel’s twiist™ automated insulin delivery system to enable improved outcomes for people living with diabetes. We currently expect the integration of the companies’ products to be available to consumers in the fourth quarter of 2025. The Sequel Collaboration subjects us to additional risks in our business operations, including but not limited to:

Previous wording

Recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at medical technologies as part of broader healthcare cost control or national security initiatives. Unlike consumer goods, medical devices are subject to unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Should additional tariffs be imposed specifically targeting medical device components, our production costs could rise significantly, and it may be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the United States, as developing and qualifying alternative sources typically requires at least several months and substantial investment and regulatory approvals. Moreover, the dynamic and unpredictable tariff and trade landscape creates substantial uncertainty and significant planning challenges for our

Current wording

Recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at medical technologies as part of broader healthcare cost control or national security initiatives. Unlike consumer goods, medical devices are subject to unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Should additional tariffs be imposed specifically targeting medical device components, our production costs could rise significantly, and it may be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the United States, as developing and qualifying alternative sources typically requires at least several months and substantial investment and regulatory approvals. Moreover, the dynamic and unpredictable tariff and trade landscape creates substantial uncertainty and significant planning challenges for our operations. Changes in tariff classifications, country-of-origin requirements, or customs procedures can occur with limited notice. This uncertainty complicates our long-term investment decisions regarding manufacturing facilities, supply chain optimization, and research and development activities.

Previous wording

As of December 31, 2024, we had 117 full-time employees. As our commercialization progresses, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, logistics, marketing, clinical/insertion services, or additional commercial activities. To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Current wording

As of December 31, 2024, we had 117 full-time employees. As our commercialization progresses, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas